2019 Instrument Cleaning and Sterilization Review and Competency
“Steam sterilization is one of the oldest methods used in healthcare facilities to sterilize medical devices and instruments. Because this method has been available for so many years, it is thought to be a simple process, one that is well understood and controlled. However, the efficacy of any sterilization process depends on a consistent system for lowering and limiting bioburden before sterilization, properly preparing items for sterilization, selecting the appropriate sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used.” (ANSI/AAMI ST79 2010, p. 1)
Suboptimal reprocessing practices can mean that instruments that have gone through the sterile processing department are returned to the operating room (OR) with human tissue, bone, or other organic material in or on the instruments.
The consequences can be disastrous for patients, staff, clinicians, and the organization. Significantly, patients are at risk of infections from dirty instruments used on them. Even if a soiled instrument is discovered before it is used on a patient, there could be procedure delays while the surgical team waits for clean instruments, possibly resulting in extended periods of time for patients under anesthesia. Disruptions from these incidents may also lead to other errors. In addition to the risks to patients (as well as the anxiety these events cause them), incidents involving improperly reprocessed instruments can damage an organization’s and its providers’ reputations, reduce patient satisfaction, result in citations and fines from regulatory bodies, prompt review by accrediting agencies, and lead to lawsuits.
OISC employees that reprocess medical devices and instruments should follow consistent processes in decontamination, preparation, packaging, sterilization and sterile storage to ensure safe patient care.
- Review point of use handling and the standardized process for case clean-up/preparation for transport to decontamination.
- Review the cleaning and decontamination process including manual cleaning, mechanical cleaning equipment, and the ultrasonic cleaner.
- Review how to properly assemble and package instruments for sterilization.
- Review key points of steam sterilization including loading the sterilizer, unloading the sterilizer, and process monitoring.
- Define immediate use steam sterilization and when it is used.
- Review the standard procedure for the receipt of loaner instrumentation from another facility or vendor.
- Review OISC’s single-use medical device reprocessing program.
- Review the proper storage of sterile instruments.
This is a two part competency that consists of a review and competency test. The test is located at the end of the review.
If you have any questions about any of the review material or you feel you need additional hands-on training, please let Nancy know.
Point of Use Handling and Decontamination
All reusable surgical instruments and devices opened on the sterile field, whether used or not, should be cleaned and decontaminated as soon as possible upon completion of the procedure according to the manufacturer’s instructions for use (IFU).
Point of Use Handling
Removing gross soil at the point of use can help prevent organic material and debris from drying on instruments. Organic material and debris are more difficult to remove from surgical instruments when they are allowed to dry.
Preparation for decontamination should begin at the point of use.
1. Wipe instruments throughout the procedure to remove gross soil.
2. Prior to transporting instruments to decontamination, remove disposable sharps and discard into a puncture-resistant container.
3.Segregate reusable sharps (i.e., trocars, punches, scissors, osteotomes) in a separate puncture proof container.
4. Keep contaminated items moist using gel-instrument pre-cleaner. Product should be used according to the manufacturer’s instructions for use (IFU).
4. Transport all instruments to decontamination in a puncture-proof, leak-proof container that is labeled BIOHAZARD (transport container, case cart).
Click on the following button to review the Case Clean-Up – Preparing Items for Decontamination presentation. Case Clean-Up
Decontamination is the use of a physical or chemical process to remove, inactivate, or destroy pathogenic organisms on the surface of an item to a point where the surface or item is made safe for handling, use or disposal.
The first and most important step in decontamination is thorough cleaning and rinsing. The purpose of cleaning and rinsing is to remove all visible debris from an item and to reduce the number of particulates, microorganisms, and potential pyrogens. Any organic material or residual cleaning agents remaining on an item can inactivate chemical disinfectants or sterilants as well as protect microorganisms from destruction.
- All staff working in decontamination must wear appropriate PPE. This includes:
- Fluid resistant front body covering with sleeves
- Gloves that are long enough to cover the cuff of the gown and halfway up the forearm
- Fluid resistant face mask and eye protection
- Liquid resistant shoe covers if there is potential for shoes becoming contaminated and/or soaked with blood or other body fluids
2. Remove items from transport containers, sort, and prepare for cleaning.
3. Disassemble surgical instruments and other items composed of more than one part or piece to expose all surfaces to the cleaning process.
4. Remove filters, process indicators, arrows, and disposable labels and locks from rigid sterilization containers. Remove interior basket from the container system.
5. Manual Cleaning
All instruments and devices should be able to be manually cleaned.
- Rinse instruments with cold running tap water or soak in cool water and/or enzymatic cleaner.
- Clean immersible devices under water to minimize aerosalization.
- Maintain the temperature of the cleaning solution between 80°F and 110°F (not to exceed 140°F).
- Change cleaning solution when soiled and when outside of temperature range.
- Clean lumens with the brush size and type recommended by the manufacturer.
- Thoroughly rinse all instruments with treated water following cleaning to ensure that loosened debris and detergents are adequately removed.
Note: Treated water is used for the final rinse to ensure that there are no staining issues and to reduce the risk of contamination of the instruments from tap water.
Removes soil and mircororganisms through an automated cleaning and rinsing process.
- Run Verify test at the beginning of the day in an EMPTY load (see procedure below)
- Operate according to the manufacturer’s IFU.
- Take apart all multi-level trays prior to placement in the washer.
- DO NOT overload.
7. Ultrasonic Cleaner
Used as a pre-treatment to remove soil from joints, crevices, lumens and other areas that are difficult to clean by other methods.
- Run Verify test weekly in an EMPTY tank (see procedure below)
- Operate according to the manufacturer’s IFU.
- Manually clean instruments or use washer-disinfector following ultrasonic cleaning.
- Change cleaning solution before it becomes heavily soiled.
8. Visually inspect all instruments, devices, containers, etc. for cleanliness. If visible soil remains, repeat cleaning procedure.
SafeStep Contamination Monitoring System
Routine testing of surgical instruments, equipment and environmental services is performed using the SafeStep Contamination Monitoring System to ensure proper cleaning and decontamination has been achieved.
The SafeStep measures the amount of light that is emitted in proportion to the amount of ATP (found in all living cells).
Case Soil Indicator
The Case Soikl Indicator provides a consistent, reproducible, “go, no-go” method to visually check the performace of the washer/disinfector. Case Soild Indicator is used to ensure a proper cleaning process and to monitor the effectiveness of equipment.
Each indicator containes a mixture of organic soils typically found on surfaces of medical devices. The cocktail of sterile blood components, proteins, lipids and carbohydrates are dried onto a stainless steel coupon to simulate bioburden on surgical devices.
Directions for Use:
- Remove the Case Soil Indicator (CSI) from the packet.
- Place the coupon into the bracket holder within the CSI case and close the lid.
- For routine testing, process in an empty chamber.
- Place in an instrument basket or tray on each shelf.
- After processing, open CSI case and remove coupon. Visually inspect at centerpoint and interpret results.
- Record results on Washer Indicator Test Record.
- PPE should be worn when handling contaminated devices.
- As the CSI may be subject to contamination from automated equipment, dispose of in a biohazard container.
Click the button to review the testing and interpretation procedure. Case Soil Indicator
Verify Ultrasonic Indicator
Ultrasonic cleaning uses cavitation, chemistry, time and temperature to effectively remove soil. Problems such as insufficient sonic energy, water level, improper temperature and degassing may have an impact on cycle outcomes. The VERIFY Ultrasonic Indicator provides an objective test to evaluate the ultrasonic cycle beyond one isolated area of the tank.
Directions for Use:
- Place one ultrasonic indicator in each of the five holders. The indicator should be placed in the spring in the inside of the holder.
- Place one holder in each of the four corners of the tray and one in the center of the tray.
- Place tray into the ultrasonic unit and run a cycle.
- After the cycle is complete, remove the holders from the tray and carefully remove the indicator from each holder. Caution should be used as the device maybe hot and any residual soil may stain.
- Inspect the indicator for evidence of soil by placing the plastic film agains a white background.
Click the button to review the Verify Ultrasonic Indicator Instructions for Use. Verify Ultrasonic IFU
SonoCheck tests for the presence of cavitation energy inside of an ultrasonic bath. It is used for routine testing to ensure proper performance.
Directions for Use:
- Prepare a bath of cleaning solution (water and detergent) according to ultrasonic and detergent manufacturer IFU.
- Run a degassing cycle prior to testing.
- Place 2 SonoChecks in an empty ultrasonic basket and place in the basket in the ultrasonic cleaner.
- Program the ultrasonic for a standard instrument cleaning cycle according to the manufacturer’s instructions.
- At end of cycle, check the SonoChecks for the appropriate color change from blue/gree to yellow within specified time.
- Record results on log sheet.
- Report if color indicates a failed test.
Assembly and Preparation for Sterilization
Following decontamination, all reusable surgical instruments are assembled and packaged in a manner that allows for sterilization of the contents, maintains the sterility of the contents until the package is opened, and provides for the removal of the contents without contamination.
- Inspect instruments during assembly for cleanliness and functionality.
- Open and unlock all jointed instruments with ratchets disengaged.
- A compatible non-linting absorbent material may be used as a tray liner to facilitate drying and/or as a wrap for use with dense items or items with unusual shape.
- Assemble instrument sets according to the manufacturer’s IFU.
- Label all packages and trays with the name of the tray or item using a non-toxic marking pen on the sterilization indicator tape, affixed labels or on the plastic side of the paper-plastic pouches.
- Trays may not exceed 25 pounds.
- Use an external chemical indicator (CI) with each package.
- Place an internal chemical indicator (CI) in each package.
- Label all items and packages with a lot control identifier that consists of:
- Sterilizer identification number
- Date of sterilization
- Cycle/load number
Inspect all packaging material for defects prior to use.
Select the correct size wrapper for item or tray.
Keep wrappers snug to prevent low spots that may collect condensate on the exterior of the package.
Wrap items or trays using the envelope or square fold wrapping technique.
- Use container system-specific filters and latch security devices.
- Inspect filters for visible holes.
- Use one filter sheet underneath each retention plate per process. (Each perforated area requires one filter).
- Place one filter over the entire filter ridge surrounding each sterilant access hole area in the container lid or bottom. (The filter material should overlap the filter ridge on all four sides and will be secured between the filter retention plate and the lid or bottom when assembled).
- Assemble the container. Place lid on container bottom and press down with smooth continuous pressure until an audible snap is heard, confirming the latch is secured.
- Insert lock.
Paper-Plastic Pouches (Peel Pack)
- Select appropriate size pouch.
- Do not use paper-plastic pouches within wrapped sets or container system sets.
- Seal the pouch according to the manufacturer’s directions.
Basins and Basin Sets
- Face basin sets so that they are facing the same direction.
- Use a layer of non-linting absorbent material between nested basin.
The sterilizer manufacturer’s IFU are used to determine sterilization parameters. Individual device manufacturer’s IFU for sterilization should also be consulted and may extend exposure parameters and dry time phases.
Loading the Sterilizer
- Group similar items requiring the same cycle parameters. Run mixed loads on the highest cycle time indicated.
- Position items that may trap water or condensate on edge and facing the same direction to facilitate drainage and drying.
- Place unwrapped items so they are not touching each other.
- Place paper-plastic pouches in a basket or holding device to keep them oriented on edge and with the plastic side of one pouch against the paper side of the neighboring pouch.
- Place container system trays flat on shelves below absorbent items such as wrapped trays, basin sets, and paper-plastic pouches.
- Place a biological indicator in the sterilizer on the bottom shelf near the door, and over the drain.
Unloading the Sterilizer
- Review the cycle time, temperature and chamber pressures and initial the printout.
- Place BI in incubator.
- Keep sterilized items on the sterilizer cart until adequately cooled.
- DO NOT TOUCH sterilized items during the cooling process.
- Keep rigid sterilization containers on the sterilizer cart until container surfaces are cool to touch and can be safely handled with bare hands.
- Inspect all items as they are removed from the sterilizer cart for external indicator change and torn or wet packaging.
- Return items for reprocessing for the following:
- External indicator didn’t change
- Package is torn or wet
- Item dropped on floor and the integrity of the packaging is compromised
The following information must be recorded and maintained for every sterilization cycle:
- Load number
- Load contents
- Exposure time and temperature (on printout)
- Name or initials of operator
- Results of CI, BI, or Bowie-Dick testing, as applicable
- Cycle related issues and actions taken, as applicable
- Release load based on physical monitors (time, temperature, and pressure), CI, and BI results.
- Loads containing a BI should not be released until results are known.
- A non-implant tray or item may be released early based on the response of the external CI, physical monitor results, and the internal CI. Document the early release and include patient identification (needs to be fully traceable to the patient) in binder.
- In an emergency, an implantable device or a tray containing an implant may be released based on the response of the external CI, physical monitor results, and the internal CI. Notify the surgeon and complete a Premature Release of Implantable Device/Tray form. Record the eventual biological test result on the Release Form.
- Notify the Administrator and surgeon if the BI results are positive following a premature release of an implant. the Administrator and surgeon should be immediately notified.
- The surgeon is responsible for notifying the patient and/or representative.
Sterilizer malfunction, failure to meet and maintain cycle parameters and/or failed CI or BI monitor results must be investigated, dentified and resolved prior to returning the sterilizer to operation.
If physical monitoring during the cycle indicates any malfunction or suspicious operation, notify Jen or designee. If the malfunction cannot be corrected immediately, terminate the cycle.
Qualification testing, consisting of three consecutive BIs run in an empty chamber, must be performed after sterilizer installation, relocation, malfunction, major repairs or after sterilization process failures.
- Remove the sterilizer from service and post a sign on the equipment.
- Notify Jen, or designee, and the Administrator.
- Contact Steris service representative.
- Return items and trays for re-packaging and re-sterilization.
- Record all actions taken on the load record.
- Perform qualification testing.
Chemical and Biological Indicators
Chemical Indicators (CIs)
CIs are designed to respond with a chemical or physical change to one or more of the physical conditions within the sterilizing chamber.
They assist in the detection of potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer.
The “pass” response of a CI does not prove that the item is sterile.
Types of CIs used at OISC
- Process Indicators (Class 1)
- Indicate that the pack, container, etc. was exposed to the sterilization process and distinguishes between processed and unprocessed.
- Referred to as external CIs.
- Sterilization indicator tape, rigid sterilization container arrows, built-in (i.e., paper-plastic pouches)
2. Indicators for use in specific tests (Class 2)
- Intended for use in specific test procedures
- Bowie-Dick test
- The 3M™ Comply™ Bowie-Dick Test Pack is used to monitor the performance of the sterilizers. Test packs will reproducibly detect residual air in the sterilizer chamber due to air leaks, air removal failures and inadequate vacuum – any of which can compromise sterility.
- Designed to react to all critical variables that meets or exceeds performance requirements
- Referred to as an internal CI
- Place in an area of the package, tray, container, etc. that is considered least accessible to steam penetration
- Place on each level of multi-level trays
- Interpreted at time of use
Biological Indicators (BIs)
BIs consist of living spores and incubation media.
They provide the only direct measure of lethality of the sterilization process.
They must be incubated until it is determined whether the microorganisms grow (they survived the sterilization process) or fail to grow (they were killed by the sterilization process).
OISC uses the 3M Attest Super Rapid Readout that provides results in 1 hour.
Click on the following link to view a 12 minute system training video. 3M Attest Super Rapid Readout
Immediate Use Steam Sterilization (IUSS)
“Immediate-Use” is broadly defined as the shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field.
Immediate use steam sterilization (IUSS) should only be performed when there is insufficient time for terminal sterilization. It should not be used as a substitute for maintaining sufficient inventory of instruments.
It may only be performed if all of the following conditions are met:
- Device manufacturer’s IFU includes instructions for IUSS
- Manufacturer’s IFU is available and followed
- Item(s) are placed in a sterilization container intended for IUSS
- Measures are taken to prevent contamination during transfer to the sterile field
Immediate use steam sterilization (IUSS) should not be used for implants. If no other option is available and IUSS is unavoidable, the cycle selection should be determined by the manufacturer’s IFU.
Items must go through the same decontamination procedure as for terminal sterilization. Since IUSS cycles usually have little or no dry time, the items processed are assumed to be wet at the conclusion of the cycle.
Use external and internal CIs with each package/container.
Perform IUSS in the sterilizer in the substerile with immediate access to the OR.
- Place item in inner basket of Steriset container (Arthro tray) with internal CI
- Place cover on container. DO NOT LATCH!
- Run cycle labeled “Load Number 1”
Items subjected to IUSS that are not immediately used cannot not be stored for later use or held for another case.
Document the date, item(s), reason for IUSS and place a patient sticker in the IUSS log book.
Receiving and Reprocessing Loaner Instrumentation
Loaner instruments from another facility or vendor must be delivered to OISC with enough time for inspection, decontamination, and sterilization.
Upon delivery, verify:
- Correct system
- Correct number of trays
- Receipt of inventory list (packing slip)
Obtain manufacturer’s IFU if not already on file.
After use, clean/disinfect instruments according to IFU prior to vendor pick-up/leaving the facility to ensure safe handling and transport.
Single-Use Medical Device Reprocessing
A contracted third party performs the reprocessing and remanufacturing of select single-use devices (SUDs).
Transport all SUDs to be reprocessed to decontamination.
Clean and disinfect SUDs according to the vendor’s instructions (posted in decontamination).
Once dry, place devices in the vendor reprocessing collection bin.
Place opened, unused supplies in a separate collection bin.
Items Used Within the Sterile Field
Inspect all items immediately before opening for proper packaging, processing, seal, package container integrity, and inclusion of sterile indicator.
- Visually verify external indicators prior to unlocking rigid containers, during opening of peel packs and/or breaking the seal of sterilization tape.
- Inspect locks to verify there has not been a breach of the container seal.
- Check and verbally confirm that the filters in the lid and container base in rigid containers are present and correctly placed.
Inspect and confirm CIs for appropriate color change for sterilization.
If an expiration date is provided, check the date before the package is opened. DO NOT USE outdated items.
Store sterile items far enough away from the floor, the ceiling, and outside walls to allow for adequate air circulation, ease of cleaning and compliance with local fire codes.
- Store items 8-10 inches off the floor
- 18 inches below the ceiling or the level of the sprinkler heads
- 2 inches from outside walls
Do not store supplies on floors or windowsills.
Store seldom-used supplies in designated covered cart.
Use a plastic bin or sheet on the bottom shelf of open-shelf (wire) carts to protect from traffic and housekeeping activities.
Do not use outside shipping containers and corrugated cartons as storage containers.
The shelf life of a packaged sterile item is event-related and depends on the quality of the packaging material, the storage conditions, the conditions during transport, and the amount of handling.
All sterile wrapped packages are considered sterile as long as the integrity of the package is maintained.
Sterile wrapped packages with a sterilization date greater than the Manufacturer’s Instructions for Use will be removed from inventory and reprocessed.
Inspect all items prior to use. Do not use if the seal is broken or the package is torn, wet or damaged.
Rotate all sterile supplies to ensure that the “old” supplies are used prior to “new” supplies.